Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer | NCT02007512 | Trialant

Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer | NCT02007512 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Willing and able to provide informed consent;

Postmenopausal;

Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal;

Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;

Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;

Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;

Eastern Cooperative Oncology Group (ECOG) status of 0 or 1;

Exclusion Criteria:

Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;

Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator;

Current or previously treated brain metastasis or leptomeningeal disease;

Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible);

Requires treatment for tuberculosis or HIV infection;

Radiation therapy within 7 days before randomization;

History of another invasive cancer within 5 years before randomization;

History of seizure or any condition that may predispose to seizure;

Clinically significant cardiovascular disease;

Active gastrointestinal disorder;

Major surgery within 28 days prior to randomization;

Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization;

Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor;

Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides;

Hypersensitivity reaction to exemestane.

ATTN-Research Pharmacist

Aurora, Colorado 80045, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado 80045, United States

University of Colorado Hospital, Anschutz Outpatient Pavilion

Aurora, Colorado 80045, United States

Rocky Mountain Cancer Centers

Colorado Springs, Colorado 80907, United States

Rocky Mountain Cancer Centers

Lakewood, Colorado 80228, United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado 80124, United States

Florida Cancer Specialists

Altamonte Springs, Florida 32701, United States

Florida Cancer Specialists

Bonita Springs, Florida 34135, United States

Florida Cancer Specialists

Bradenton, Florida 34209, United States

Florida Cancer Specialists

Brandon, Florida 33511, United States

Florida Cancer Specialists

Cape Coral, Florida 33909, United States

Florida Cancer Specialists

Clearwater, Florida 33761, United States

Florida Cancer Specialists

Englewood, Florida 34223, United States

Florida Cancer Specialists

Fort Myers, Florida 33901, United States

Florida Cancer Specialists

Fort Myers, Florida 33905, United States

Florida Cancer Specialists

Fort Myers, Florida 33908, United States

Florida Cancer Specialists

Gainesville, Florida 32605, United States

Florida Cancer Specialists

Hudson, Florida 34667, United States

Florida Cancer Specialists

Largo, Florida 33770, United States

Florida Cancer Specialists

Naples, Florida 34102, United States

Florida Cancer Specialists

New Port Richey, Florida 34655, United States

Florida Cancer Specialists

Orange City, Florida 32763, United States

Florida Cancer Specialists

Orlando, Florida 32806, United States

Florida Cancer Specialists

Port Charlotte, Florida 33980, United States

Florida Cancer Specialists

Sarasota, Florida 34232, United States

Florida Cancer Specialists

Sarasota, Florida 34236, United States

Florida Cancer Specialists

Spring Hill, Florida 34608, United States

Florida Cancer Specialists

St. Petersburg, Florida 33705, United States

Florida Cancer Specialists

Tampa, Florida 33607, United States

Florida Cancer Specialists

Tavares, Florida 32778, United States

Florida Cancer Specialists

Venice, Florida 34285, United States

Florida Cancer Specialists

Venice, Florida 34292, United States

Northwestern Medical Faculty Foundation

Chicago, Illinois 60611, United States

Northwestern Memorial Hospital

Chicago, Illinois 60611, United States

The University of Chicago Medical Center,

Chicago, Illinois 60637, United States

The University of Chicago

Chicago, Illinois 60637, United States

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois 60451, United States

Indiana University Health Hospital

Indianapolis, Indiana 46202, United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202, United States

Investigational Drug Services

Indianapolis, Indiana 46202, United States

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana 46202, United States

Springmill Medical Clinic

Indianapolis, Indiana 46290, United States

Brigham and Women's Hospital

Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215, United States

Minnesota Oncology Hematology, P.A

Minneapolis, Minnesota 55404, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota 55407, United States

Allina Health System DBA Virginia Piper Cancer Institute

Minneapolis, Minnesota 55407, United States

Dr.Michaela Tsai

Minneapolis, Minnesota 55407, United States

The West Clinic, P.C.

Corinth, Mississippi 38834, United States

The West Clinic, P.C. d/b/a West Cancer Center

Southaven, Mississippi 38671, United States

Siteman Cancer Center

City of Saint Peters, Missouri 63376, United States

Barnes-Jewish Hospital

St Louis, Missouri 63110, United States

Washington University Infusion Center Pharmacy

St Louis, Missouri 63110, United States

Washington University School of Medicine

St Louis, Missouri 63110, United States

Siteman Cancer Center-South County

St Louis, Missouri 63129, United States

Siteman Cancer Center- West County

St Louis, Missouri 63141, United States

Hematology Oncology Associates of Northern NJ

Morristown, New Jersey 07962, United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio 45202, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio 45211, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio 45230, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio 45236, United States

Oncology Hematology Care, Inc.

Cincinnati, Ohio 45242, United States

Oncology Hematology Care, Inc.

Fairfield, Ohio 45014, United States

Greenville Health System

Greenville, South Carolina 29605, United States

Greenville Health System

Seneca, South Carolina 29672, United States

Greenville Health System

Spartanburg, South Carolina 29307, United States

Tennessee Oncology, PLLC

Franklin, Tennessee 37067, United States

Tennessee Oncology, PLLC

Gallatin, Tennessee 37066, United States

The West Clinic, P.C. d/b/a West Cancer Center

Germantown, Tennessee 38138, United States

Tennessee Oncology, PLLC

Hermitage, Tennessee 37076, United States

Tennessee Oncology, PLLC

Lebanon, Tennessee 37090, United States

The West Clinic, P.C. d/b/a West Cancer Center

Memphis, Tennessee 38104, United States

Tennessee Oncology, PLLC

Murfreesboro, Tennessee 37129, United States

Tennessee Oncology, PLLC

Nashville, Tennessee 37203, United States

The Sarah Cannon Research Institute

Nashville, Tennessee 37203, United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee 37204, United States

Vanderbilt Health Pharmacy One Hundred Oaks

Nashville, Tennessee 37204, United States

Tennessee Oncology, PLLC

Nashville, Tennessee 37207, United States

Tennessee Oncology, PLLC

Nashville, Tennessee 37211, United States

Henry-Joyce Cancer Clinic

Nashville, Tennessee 37232, United States

Tennessee Oncology, PLLC

Shelbyville, Tennessee 37160, United States

Tennessee Oncology, PLLC

Smyrna, Tennessee 37167, United States

Texas Oncology - Memorial City

Houston, Texas 77024, United States

Texas Oncology-Longview Cancer Center

Longview, Texas 75601, United States

Texas Oncology - Tyler

Tyler, Texas 75702, United States

Virginia Cancer Institute

Mechanicsville, Virginia 23116, United States

Virginia Cancer Institute

Richmond, Virginia 23230, United States

Virginia Cancer Institute

Richmond, Virginia 23235, United States

UZA

Edegem, Antwerpen 2650, Belgium

GZA

Wilrijk, Antwerpen 2610, Belgium

Institut Jules Bordet

Brussels, 1000, Belgium

Sunnybrook Research Institute

Toronto, Ontario M4N 3M5, Canada

McGill University Health Center- Cedars Cancer Center

Montreal, Quebec H4A 3J1, Canada

McGill University Health Centre - Cedars Cancer Centre

Montreal, Quebec H4A 3J1, Canada

Pharmacy Department

Dublin, 4, Ireland

Radiology Department

Dublin, 4, Ireland

St Vincent's University Hospital

Dublin, 4, Ireland

Institute for Cancer Research

Dublin, 7, Ireland

Mater Private Hospital

Dublin, 7, Ireland

Pharmacy Department

Dublin, 7, Ireland

Radiology Department

Dublin, 7, Ireland

Cancer Clinical Trials Unit

Dublin, D9, Ireland

Pharmacy Department

Dublin, D9, Ireland

Radiology Department

Dublin, D9, Ireland

Institute for Cancer Research

Dublin, Ireland

Mater Private Hospital

Dublin, Ireland

Pharmacy Department

Dublin, Ireland

Radiology Department

Dublin, Ireland

IRCCS Ospedale San Raffaele

Milan, MI 20132, Italy

Divisione di Senologia Medica; Istituto Europeo di Oncologia

Milan, MI 20141, Italy

A.O.di Perugia S. Maria Della Misericoridia

Perugia, PG 06132, Italy

Azienda Ospedaliera S.Orsola Malpighi

Bologna, 40138, Italy

U.O. Farmaceutica, Nuovo Ospedale di Prato

Prato, 59100, Italy

U.O. Oncologia Medica, Nuovo Ospedale di Prato

Prato, 59100, Italy

Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid 28660, Spain

Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus

Barcelona, 08028, Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Hospital Universitario 12 Octubre

Madrid, 28041, Spain

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Hospital de Madrid Norte Sanchinarro

Madrid, 28050, Spain

Brighton and Sussex University Hospital NHS Trust

Brighton, England BN2 5BE, United Kingdom

Pharmacy Department

Brighton, England BN2 5BE, United Kingdom

Radiation Safety Service, Medical Physics Department

Brighton, England BN2 5BE, United Kingdom

Histopathology Department

Nottingham, England NG5 1PB, United Kingdom

Nottingham University Hospital

Nottingham, England NG5 1PB, United Kingdom

Pharmacy Department

Nottingham, England NG5 1PB, United Kingdom

Radiology Department

Nottingham, England NG5 1PB, United Kingdom

Radiology Department

Nottingham, England NG7 2UH, United Kingdom

Department of Radiology

Truro, England TR1 3LJ, United Kingdom

Pharmacy Department

Truro, England TR1 3LJ, United Kingdom

Royal Cornwall Hospitals NHS trust

Truro, England TR1 3LJ, United Kingdom

Clinical Investigation & Research Unit

Brighton, Sussex BN2 5BE, United Kingdom